Project Manager, Engineering

Polysciences technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. We are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical device, specialty chemical and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA’s ChemStewards® Management System. We believe the best scientific innovations are built through collaborations.

Our Catalog Business, offering researchers and scientists worldwide access to an extensive range of high-quality reagents and specialty chemicals. Our extensive catalog spans thousands of products, serving a spectrum of applications in life sciences, materials sciences, and beyond. We take pride in the significant impact our products have made within the academic community, evidenced by thousands of citations in scholarly literature. By facilitating innovation, we empower researchers to advance their scientific endeavors with confidence.

Our bioprocessing business unit develops, markets and sells innovative, proprietary solutions for research, bioproduction and therapeutics development. Our products are enrolled in a growing number of clinical trials worldwide.

Our specialty products business unit designs, replicates or refines formulations, optimizes analytical methods and develops scalable production processes of fine chemicals with a range of applications, such as biocompatible polymers and polymer precursors for medical devices, bioresorbable polymers for drug elution systems, high-end specialty industrials, energetic additives, and hard-to-find chemicals.

Our Contract Manufacturing business unit provides solid, liquid, and high viscosity custom blending and bottle, drum, tube, and pouch filling to our customers. Capabilities include hot-pour, emulsion and gel materials, flammable & hazardous, WFI grade and DI water, ISO 5 or 8 cleanrooms, and in-line labeling.

The Project Manager is responsible for developing, optimizing and monitoring processes and systems. The Project Manager is responsible for the guidance of projects and products through the design and development process. They are responsible for working with a cross functional team of Sales, R&D, Engineering, Quality, Production, etc. to onboard new projects and drive them through the development process to commercialization.

Essential Functions

• Support commercial production and online troubleshooting for both the process and associated equipment.
• Support the design and development of robust commercial manufacturing, cleaning, filling and packaging processes utilizing design of experiments and statistical rationale.
• Work collaboratively with a cross functional team (Sales, R&D, Quality, QC, Production, EHS, etc.) to manage the progression of products through development and validation to commercialization.
• Construct project timelines, monitor adherence, communicate progression, and work with the respective resources to remove obstacles to advance projects through development.
• Author supporting process development documents such as SOPs, Batch Records, Protocols and Reports.
• Assist in Nonconformance and OOS investigations to drive to root cause and implement effective CAPAs to mitigate repeat events.
• Support continuous improvement for established products to define more efficient processes.
• Support installation and qualification of manufacturing equipment for commercial production, with the engineering team as necessary.
• Support new project quoting in regards to high-level process and equipment design.
• Organize and manage internal and external project meetings and communications throughout product development.
  
  

Qualifications

Proficiency with Microsoft Word and Excel required.

Experience with statistical software such as Minitab, JMP or Stat-Ease preferred.

Familiarity with SAP or similar ERP system and Blue Mountain or similar CMMS preferred.

Understanding of project management software such as Monday.com or Microsoft Project preferred.

Other Qualifications

• Bachelor’s degree in Engineering, chemical, industrial or mechanical required, additional education preferred.
• Experience working in an ISO 13485 or FDA GMP environment preferred.
• Experience with customer communications such as emailing, conference calling, and visit hosting required.
• Ability to create project timelines, organize internal teams and drive projects from initial PO through sustained commercial production preferred.
• Ability to manage third party testing and storage laboratories to support product development.
• Expertise in process scale-up, optimization, cleaning and validation activities preferred.
• Knowledge of equipment specification and qualification preferred.